Transcatheter Aortic Valve Implantation With the Edwards SAPIEN Versus the Medtronic CoreValve Revalving System Devices A Multicenter Collaborative Study: The PRAGMATIC Plus Initiative (Pooled-RotterdAm-Milano-Toulouse In Collaboration)

A Chieffo, GL Buchanan, Nicolas van Mieghem, D Tchetche, N Dumonteil, A Latib, Robert van der Boon, O Vahdat, B Marcheix, B Farah, PWJC (Patrick) Serruys, J Fajadet, D Carrie, Peter de Jaegere, A Colombo

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Objectives The aim of this study was to compare outcomes after transfemoral transcatheter aortic valve implantation with the Medtronic CoreValve (MCV) versus the Edwards SAPIEN/SAPIEN XT transcatheter heart valve (ESV) for severe aortic stenosis. Background No large matched comparison study has been conducted so far evaluating both commercially available devices. Methods The data from databases of 4 experienced European centers were pooled and analyzed. Due to differences in baseline clinical characteristics, propensity score matching was performed. Study objectives were Valve Academic Research Consortium outcomes at 30 days and 1 year. Results In total, 793 patients were included: 453 (57.1%) treated with the MCV and 340 (42.9%) with the ESV. After propensity matching, 204 patients were identified in each group. At 30 days, there were no differences in all-cause mortality (MCV, 8.8% vs. ESV, 6.4%; hazard ratio [HR]: 1.422; 95% confidence interval [CI]: 0.677 to 2.984; p = 0.352), cardiovascular mortality (MCV, 6.9% vs. ESV, 6.4%; HR: 1.083; 95% CI: 0.496 to 2.364; p = 0.842), myocardial infarction (MCV, 0.5% vs. ESV, 1.5%; HR: Conclusions No differences between the 2 commercially available transfemoral transcatheter aortic valve implantation devices were observed at the adjusted analysis in Valve Academic Research Consortium outcomes except for the need for permanent pacemakers with the MCV. (J Am Coll Cardiol 2013;61:830-6) (c) 2013 by the American College of Cardiology Foundation
Original languageUndefined/Unknown
Pages (from-to)830-836
Number of pages7
JournalJournal of the American College of Cardiology
Issue number8
Publication statusPublished - 2013

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